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Category Archives: ISO

Share on Google+ November 12, 2018

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American Preclinical Services: Extractables and Leachables Program

Category : Analytical, Chemical Characterization, Extractable/Leachable, ISO

APS is a State of the Art, AAALAC and ISO17025 accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN specializing in medical device and pharmaceutical testing. In addition to biocompatibility testing, interventional, surgical, toxicology, pharmacology, pain, physician training, bioskills, animal model development, and complete pathology services, APS has expended its services to include analytical services.

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Share on Google+ June 12, 2017

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Pathology Matters, part 1 of a 3 part series: Preclinical Studies and Histopathology

Category : Histopathology, Interventional Medicine, ISO, Medical Device testing

The histopathology evaluation in preclinical studies is performed to support the study objectives. The study type, tissues examined, and intended data use all determine what pathology analysis is needed. Here we review the preclinical studies that rely heavily on histopathology data. Histopathology is a key component of these preclinical study types: Device safety studies Biocompatibility studies Systemic toxicity studies These

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Share on Google+ September 18, 2015

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New Directions in ISO-10993-4 Hemocompatibility Testing of Medical Devices

Category : ISO

Don’t miss Kent Grove on Tuesday 9/22/15 at the 25th Annual BioInterface Workshop & Symposium. Kent will be discussing new updates in both in vivo and in vitro hemocompatibility and thrombogenicity testing. Kent was an invited speaker at the FDA workshop on Methods for Thrombogenicity Testing, held on April 14, 2014.  Kent has also championed a new minimally heparinized in

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Share on Google+ August 18, 2015

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BioInterface Conference Coming to Arizona

Category : ISO

The 2015 Biolnterface Conference is the hallmark annual event of the Surfaces in Biomaterials Foundation (SIBF). This year’s conference – the 25th Anniversary of the event – is scheduled for September 21-23 at the Fairmont Scottsdale Princess in Arizona. The BioInterface Conference kicks off with Workshops on Monday, Sept. 21. The theme of this year’s Workshops is Hemocompatibility Technologies, Models

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Share on Google+ June 29, 2015

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ISO/TC 194 – Biological and Clinical Evaluation of Medical Devices

Category : APS Service Offerings, In-vitro testing, In-vivo Testing, ISO, ISO/TC 194, Medical Device testing

APS Staff participated in the annual gathering of Technical Committee 194 of the International Standards Organization which is responsible for the continuing development and revisions of the guidelines for “Biological and Clinical Evaluation of Medical Devices”. The output of this committee and the associated 17 working groups is critical in the global processes standardizing biological test methods for the evaluation

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